FDA product code · Cardiovascular
Coronary Drug-Eluting Stent
15 FDA decisions since 2003. 5 recalls name this code, 0 of them Class I.
Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NIQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · NIQ
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIQ
Too few NIQ 510(k)s in any year since 2007 to give a median.
Recalls per year · NIQ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NIQ
2,471in 2025
MAUDE reports naming product code NIQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | — | 0 | 4,851 |
| 2008 | 59 | — | 0 | 5,096 |
| 2009 | 88 | — | 1 | 7,106 |
| 2010 | 82 | — | 0 | 5,839 |
| 2011 | 97 | — | 0 | 7,105 |
| 2012 | 167 | — | 0 | 8,323 |
| 2013 | 99 | — | 1 | 7,563 |
| 2014 | 128 | — | 0 | 6,666 |
| 2015 | 45 | — | 0 | 6,142 |
| 2016 | 72 | — | 0 | 7,234 |
| 2017 | 53 | — | 0 | 6,786 |
| 2018 | 61 | — | 0 | 6,817 |
| 2019 | 59 | — | 0 | 7,254 |
| 2020 | 62 | — | 0 | 6,362 |
| 2021 | 63 | — | 0 | 5,268 |
| 2022 | 45 | — | 0 | 4,068 |
| 2023 | 49 | — | 0 | 3,097 |
| 2024 | 35 | — | 0 | 3,041 |
| 2025 | 28 | — | 0 | 2,471 |
| 2026 | 27 | — | 0 | — |
Planning a device in NIQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report